483
Kohana Pharmacy and Center for Regenerative Medicine Inc.Kohana Pharmacy and Center for Regenerative Medicine Inc. – FDA 483, Apr 10, 2019
Record Details
An FDA inspection of Kohana Pharmacy and Center for Regenerative Medicine Inc. in San Luis Obispo, CA, identified significant deficiencies in the production of non-sterile drug products. The firm was cited for using non-pharmaceutical grade components, specifically purified water, in drug formulations. Additionally, the inspection revealed inadequate cleaning procedures for work surfaces and utensils used in the production of hazardous drugs, posing a risk of cross-contamination.
- Inspection date
- April 10, 2019
- Product type
- drugs
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ID · 53aa7ab8-817d-43e0-8196-65678cd3f013
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